The present invention is directed to single-use disposable applicators for applying liquid materials. More particularly, the present invention relates to single-use applicators for applying a polymerizable material such as cyanoacrylate monomers as surgical adhesives, sealants and dressings.
Various dispensing and packaging systems for cyanoacrylate-based adhesive and/or sealant material have been proposed. U. S. Pat. Appl. Pub. No. 20080167681 to Stenton discloses an adhesive applicator for applying medical adhesives to surgical incisions. The applicator comprises a receiver having a deformable cylindrical body, a blunt cylindrical body with an adhesive-permeable foam material, a frangible ampule containing adhesive material, and a pair of wings having a pressure barb facing toward the cylindrical wall to break the frangible ampule.
U.S. Pat. Appl. Pub. No. 20080105580 to Nentwick et al. discloses an applicator tip for dispensing a cyanoacrylate-based adhesive from a reservoir. The applicator tip includes an opening offset and a distal end. The adhesive material is dispensed when pressure is applied to the applicator tip surface so that the applicator tip is in a deformed configuration.
U.S. Pat. Appl. Pub. No. 20070147947 to Stenton et al. discloses an applicator for forming uniform thickness layers of liquid coating on a substrate surface. The applicator is characterized by controlling the dispensing of liquid through apertures incorporated within the applicator head. The applicator uses a supported thin layer of foam which assures uniform thickness of applied layers, which are substantially independent of the pressure applied to the applicator.
U.S. Pat. Appl. Pub. No. 20060282035 to Battisti et al. discloses a disposable swab applicator for containing and dispensing cyanoacrylate adhesive. The swab applicator is closed at one end and covered by a swab applicator with the cyanoacrylate composition contained by a valve that can be easily opened when desired. The valve can be a ball, a bead or a capsule.
The device can be heat sterilized using dry heat sterilization.
U.S. Pat. No. 7,297,217 to Dewitt discloses a dispenser for application of a special low viscosity cyanoacrylate adhesive which is used for the manufacture and repair of wooden furniture. The dispenser is provided with a closure member having a metallic pin which penetrates into the discharge opening while the closure member is being secured thereon. U.S. Pat. No. 6,779,657 to Mainwaring et al. discloses a single-use applicator assembly for applying and dispensing cyanoacrylate monomeric adhesive material. The applicator comprises a base with at least one sealed container and an applicator tip at least partially disposed in the container such that the tip of the applicator has access to the adhesive material. U.S. Pat. No. 6,547,467 to Quintero discloses a microapplicator for dispensing and applying cyanaocrylate-based adhesive. The microapplicator comprises a handle portion, a microerservoir at the applicator tip to hold about 20 microliter or less, of adhesive material. The applicator tip may include a spatula, a rolling ball, a grate, a porous material, and a brush. U.S. Pat. No. 5,649,648 to Lier et al. discloses a packaging system for free-flowing material such as cyanoacrylate adhesive. The package comprises a container and a closable applicator point fitted on its outlet aperture. The container is made of an extruded receptacle aluminum which springs back when the pressure is released. U.S. Pat. No. 4,685,591 to Schaefer et al. discloses a packaging tube that is suitable for storing and dispensing products containing substantial fractions of cyanoacrylates. The tube sidewall is made of multi-layer sheet material and a covering strip is placed over the inside surface the tube. U.S. Pat. No. 4,413,753 to Stock discloses a self-draining tip for dispensing cyanoacrylate adhesives. The dispensing tip includes a single or segmented constant diameter passageway having sharp-edged annular terminations for dispensing.
Closure Medical Corporation prepared and published a series of patents in terms of applying and dispensing cyanoacrylate adhesives. For example, U.S. Pat. Appl. Pub. No. 20050175395, U.S. Pat. Nos 7,306,390 and 6,705,790 to Quintero et al. discloses an applicator assembly for dispensing adhesive material. The applicator comprises first and second body portions, a frangible ampule container for adhesive, and a breaking member to rupture the container for dispensing the adhesive material. U.S. Pat. Nos 6,960,040, 6,494,896, and 6,340,097 to D'Alessio et al. disclose package assembly suitable for laparoscopic or endoscopic surgery. U.S. Pat. Nos 7,128,241, 6,676,322, 6,376,019, 6,322,852, 6,099,807, 5,928,611 to Leung discloses an applicator tip for dispensing cyanoacrylate adhesive stored in a frangible glass ampule container. The porous, absorbent applicator tip includes a polymerization initiator to accelerate the polymerization of cyanoacrylate adhesive when applied. The DERMABOND® applicator associated with most patents mentioned above comprises a glass ampule for storing adhesives and a porous applicator tip incorporating a polymerization initiator. As published by FDA in the Maude Adverse Event Report, the glass vial of the DERMABOND® applicator was crushed and the shard protruded through the tube, penetrated the gloves and pierced the hands of the medical professionals or the patients. The shard penetration adverse effect of DERMABOND® occurred repeatedly since it was marketed. The breakage or rupture of broken glass through the outside plastic package exposes the user or patient to risk. Another problem associated with this type of applicator is the clogging of the applicator tip. The presence of polymerization initiator in the applicator tip can lead to rapid polymerization of cyanoacrylate adhesives to clog the applicator, which causes the waste of adhesive material. The clogging of the applicator may delay the wound closure process during surgery, which may result in problems for both patients and surgical professionals.
Besides safety and the clogging problem, the prior applicator devices exhibit other shortcomings. The lack of flow rate control of adhesive is one of the issues surgical doctors often face. A further inconvenience which has occurred in prior applicators is the requirement of two hands to operate. Furthermore, the design and dispensing mechanism of some of the prior applicators are very complicated and thereby very expensive. More importantly, the known applicators fail to be compatible with irradiation sterilization techniques so that cyanoacrylate adhesives inside either cannot be sterilized by irradiation sterilization, such as electron beam, gamma, and X-ray, or cannot provide a stable shelf life after sterilization in such applicator. Therefore, a need exists for new applicator designs, which are easy to use, safe due to the absence of glass, capable of controlling flow rate, compatible with irradiation sterilization techniques, exhibits no clogging of the applicator tip, and causes no waste of adhesives.